Biophytis Receives FDA Approval to Proceed with the MYODA Program for Clinical
Development of Sarconeos (BIO101) in Patients with Duchenne Muscular Dystrophy
Paris (France), Cambridge (Massachusetts, U.S.), December 16, 2019, 8:00 a.m.
CET - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company with a primary focus on the development of its lead drug
candidate, Sarconeos (BIO101) for the treatment of neuromuscular diseases,
today announces that it has received the approval from the U.S. Food and Drug
Administration (FDA), neurology division, that it can proceed with its clinical
investigation of a pediatric formulation of Sarconeos (BIO101) in patients with
Duchenne muscular dystrophy (DMD). This follows the FDA's completion of the
safety review of the IND application (IND 140530) filed by Biophytis in
Samuel Agus, M.D., Chief Medical Officer of Biophytis, said: "We are very
pleased to have received the message that we may proceed with the MYODA
clinical program. Following encouraging preclinical data, we believe Sarconeos
(BIO101) has the potential to be a much- needed treatment for DMD patients, a
devastating disease with limited treatment options currently available."
The MYODA clinical program is an adaptive seamless Phase 1 to 3 clinical study,
utilizing a composite score as the primary endpoint to assess the safety and
efficacy of a pediatric formulation of Sarconeos (BIO101) for both ambulatory
and non-ambulatory patients with DMD.
Stanislas Veillet, Chief Executive Officer of Biophytis, said: "This is a great
milestone for Biophytis and outlines the dedication and hard work of our team.
We are grateful for the detailed guidance we have received from the regulatory
agencies in designing our MYODA clinical program."
Biophytis is a clinical-stage biotechnology company focused on developing
therapeutics that slow the degenerative processes associated with aging and
improve functional outcomes for patients suffering from age-related diseases,
with a primary focus on neuromuscular diseases.
Biophytis' lead drug candidate, Sarconeos (BIO101), is an orally administered
small molecule, which is currently in a Phase 2b clinical trial for sarcopenia
(SARA-INT) in the US and Europe. Biophytis has developed a pediatric
formulation of Sarconeos (BIO101) for the treatment of Duchenne muscular
dystrophy (DMD), which is expected to start a Phase 2 clinical trial in 2020.
Biophytis' preclinical drug candidate, Macuneos (BIO201), is an orally
administered small molecule in development for the treatment of retinopathies,
including dry age-related macular degeneration (AMD) and Stargardt disease.
Biophytis is headquartered in Paris, France, and has offices in Cambridge,
Massachusetts. The Company's ordinary shares are listed on Euronext
Growth Paris (Ticker: ALBPS - ISIN: FR0012816825). For more information please
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